Effect of Ropinirole on Spinal Cord Reflexes and Restless Legs Syndrome

Exclusion Criteria

• •1. History of any medical condition that can reasonably be expected to subject the individual to unwarranted risk or compromise scientific integrity of the study;
• •2. History or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion drugs
• •3. Clinically significant laboratory abnormalities including liver enzyme elevation greater than twice the upper limit of normal;
• •4. Patient unwilling or unable to stop their usual medications for RLS;
• •5. Subjects unable or unwilling to discontinue a prohibited concomitant medication;
• •6. Subjects who have received prescribed medication within 7 days prior to the first dosing day (defined as Day 1), which in the opinion of the Principal Investigator will interfere with the study procedures or compromise safety.
• •7. Withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit or induce CYP1A2 within 2 weeks prior to first dose (Day 1).
• •8. Patients suffering from RLS symptoms during the daytime (daytime defined as 10.00 until 16.00 hours).
• •9. Subjects who have not been using a clinically accepted contraceptive method (such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception) for the last 30 days, or is not at least one year post-menopausal (if female);
• •10. Subjects who are pregnant or breastfeeding;
• •11. Subjects with cognitive impairment (MMSE less than 25);
• •12. Subjects who have participated in a clinical study with an investigational drug within the last 3 months;
• •13. Subjects with history or presence of active drug or alcohol abuse that, in the opinion of the investigators, would interfere with compliance or safety or scientific integrity of study;
• •14. Subjects unwilling to sign an informed consent or to comply with protocol requirements.
• •15. A dissomnia or parasomnia other than, in patients, primary RLS (e.g. narcolepsy, sleep tenor disorder, sleepwalking disorder, and breathing-related sleep disorder), either from clinical review or from polysomnography (including subjects with apnea hypopnea index greather than 5/h).
• •16. Signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anemia or pregnancy at baseline).
• •17. Subjects with clinical and/or biochemical evidence of iron deficiency.
• •18. Subjects with a diastolic blood pressure greater than or equal to 110mmHg or less than or equal to 50mmHg OR systolic blood pressure greater than or equal 180mmHg or less than or equal 90mmHg at baseline.
• •19. Subjects with known intolerance to ropinirole or other dopaminergic agonist.
• •20. Patients with symptomatic orthostatic hypotension.